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Trial - NCT04868942


Column Value
Trial registration number NCT04868942
Full text link
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04868942

First author
Last imported at : Dec. 31, 2021, 5 a.m.
Source : ClinicalTrials.gov

Fabrice Simon, Prof

Contact
Last imported at : Dec. 31, 2021, 5 a.m.
Source : ClinicalTrials.gov

simon-f@wanadoo.fr

Registration date
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

2021-05-03

Recruitment status
Last imported at : Dec. 31, 2021, 5 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : May 15, 2021, 12:32 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - student at aix marseille university - who has declared that he or she does not carry any risk factor for severe forms of the disease (hcsp criteria of 29/10/2020) - who has declared that he or she does not live under the same roof as a person who does carry such factors, and committed to strictly following the study's health protocol, - carrying a smartphone which is registered on the "tousanticovid" application (with bluetooth activation), and agreeing to install the maela application on the smartphone for remote medical monitoring.

Exclusion criteria
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

- volunteer with clinical signs of acute respiratory infectious disease - volunteer living with a person with clinical signs of acute respiratory infectious disease - volunteer with a risk factor for severe covid-19 - volunteer who had a covid-19 infection in the 3 months prior to the study - volunteer who are not affiliated to the social security system - volunteer vaccinated against covid-19 - pregnant women and people living with pregnant women - persons deprived of liberty - adult with legal protection - volunteer unable to comply with protective measures, at the concert or at home - volunteer participating in another clinical research study

Number of arms
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

ANRS, Emerging Infectious Diseases

Inclusion age min
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

29

Countries
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Dec. 31, 2021, 5 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

SARS-CoV-2 conversion rates

Notes
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

Not reported

Arms
Last imported at : May 5, 2021, 11:25 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 866, "treatment_name": "National protective measures", "treatment_type": "Public health program", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]